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Not Yet Recruiting NCT07673211

Circulating cfDNA and HPV as Prognostic Biomarkers for First-Line Recurrent Metastatic Cervical Cancer

Conditions: Cervical Cancer, Recurrent Cervical Cancer, Metastatic Cervical Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 60
Sponsor: Zhejiang Cancer Hospital

Summary

Primary Objective of this study: To investigate the correlation between longitudinal quantitative dynamics of circulating tumor DNA (ctDNA) and HPV-derived cell-free DNA (HPV cfDNA) in peripheral blood and clinical prognosis among patients with recurrent and metastatic cervical cancer who achieved complete response following standard first-line systemic therapy.

Eligibility Criteria

Inclusion Criteria: 1. Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 2. Patients with first recurrent or metastatic cervical cancer (including primary stage IVB disease); 3. Received standard first-line therapy (TP/TC regimen plus immunotherapy ± bevacizumab); 4. Achieved complete response (CR) following standard first-line treatment; 5. Archived pathological biopsy specimens of recurrent/metastatic lesions prior to treatment available in our hospital; 6. Participated in clinical trials of pharmaceutical therapy for first-line recurrent/metastatic cervical cancer conducted at our institution; 7. Voluntarily participates in this study and provides written informed consent; 8. Agrees to serial peripheral blood collection at scheduled time points; 9. Willing to complete scheduled follow-up visits; 10. Aged ≥ 18 years old. Exclusion Criteria: 1. History of other malignant tumors within the past 2 years; 2. Pregnant or breastfeeding women; 3. Severe concomitant diseases, including: cardiovascular diseases (e.g., uncontrolled heart failure, unstable angina, etc.); pulmonary diseases (e.g., severe chronic obstructive pulmonary disease, interstitial pneumonia and other conditions impairing respiratory function); hepatic and renal dysfunction (e.g., decompensated liver cirrhosis, severe renal failure requiring dialysis, etc.); 4. Refusal to sign informed consent; 5. Refusal to undergo serial blood collection.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07673211). StuddyBuddy aggregates publicly available trial information.